US industry association promotes an exchanges with Japan on bioclusters, while continuing to push for holistic debate on reforms to the country’s national healthcare system and changes to reimbursement pricing it sees as supporting innovation.
The US research-based industry group The Pharmaceutical and Research Manufacturers of America (PhRMA) is continuing to advocate for broad debate around reforms to Japan’s healthcare and drug reimbursement pricing systems, as it seeks to create an environment it sees as conducive to sustainable innovation, patient access to new drugs and economic benefits.
While many of the themes are familiar, one particular emphasis this year was a healthcare innovation roundtable, under which the...
Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.
The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting reimbursement prices. How has the sector panned out over the last decade?
A Japanese approval for Lilly's Alzheimer's drug donanemab is expected soon following a positive recommendation from the MHLW. The ministry has also announced reimbursement prices for 12 new products including Fabhalta, along with price cuts for Tezspire, Dupixent and competitors following a review.
Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.
The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
